MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-08-19 for SENSORMEDICS VMAX 229 * manufactured by Sensor Medics Corp..
[156326]
Sensormedics vmax 229 pulmonary function system consistently underestimates the lung volume determination in pts with copd. System uses nitrogen washout method to measure lung volume. Replaced modules and received software upgrade with no change in results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1016971 |
| MDR Report Key | 237110 |
| Date Received | 1999-08-19 |
| Date of Report | 1999-08-17 |
| Date Added to Maude | 1999-08-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSORMEDICS |
| Generic Name | PULMONARY FUNCTION ANALYZER |
| Product Code | BZM |
| Date Received | 1999-08-19 |
| Model Number | VMAX 229 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | 963009010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 229783 |
| Manufacturer | SENSOR MEDICS CORP. |
| Manufacturer Address | 22705 SAVI RANCH PKWY YORBA LINDA CA 92687 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-08-19 |